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ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 26GA (1.9F) X 30CM
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for evaluation. A follow-up report will be submitted once the sample has been received and reviewed.
Event Description
¿i had 2 lcath 1. 9fr catheters break on me last night. Lot number 11347875 and lot 11332530. It was when i went to remove the guidewire. I had pre-flushed them but they accordioned and broke at the purple part. It was extremely frustrating because i had to place a 1. 2fr in a (b)(6) kg baby after placing 2 of the 1. 9. ".
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Brand NameL-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of DeviceL-CATH PICC
Manufacturer (Section D)
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key11634934
MDR Text Key246236402
Report Number1625425-2021-00901
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number26GA (1.9F) X 30CM
Device Catalogue Number384539
Device Lot Number11332530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1